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Is Your Sterile Injectable Ready for Changes in Raw Materials?

In any manufacturing company, it is likely that raw material will change from time to time.  These changes are modifications in API synthesis, key starter materials and intermediates.  These changes are expected and necessary for manufacturing improvement.  The best approach to alternating materials from a supplier, is to always keep track and maintain data and…
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Is your Equipment Qualified?

The slightest error or misuse of equipment could lead to an expensive risk, delay manufacturing of a product and minimize the amount of sales.  It is necessary to have all items involved in the manufacturing process go through a qualification test.  Equipment qualification is extremely critical.  Qualification needs to be documented and recorded for both…
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Greenpark Compounding Pharmacy Ophthalmic Recall

Greenpark Compounding Pharmacy produced and distributed compounded products from Prescription Labs Inc. nationwide.  These products are intended to be sterile and could be life-threatening if used when not sterile. FDA discovered in July/August that the conditions of Greenpark Compounding Pharmacy’s facility could be causing contamination to the compounded drugs they were manufacturing.  On August 18…
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Innovation Begins with a Problem

Dr. Thomas Ingallinera from Pharmaceuticals International Inc. has a motto, “challenges frame opportunities”.  This motto supports many situations within the pharmaceutical industries as well as others.  When companies face issues, that is when they decide that they need to make changes and updates.  This system is not always the best, because when a problem occurs,…
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